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Vitamin D3 (Cholecalciferol) Uses, Benefits, Dosage & Side Effects | DrugsAtlas

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Therapeutic Class

Vitamin / Nutritional supplement

Subclass

Fat-soluble vitamin

Speciality

Endocrinology

Schedule (India)

Schedule H: High-dose formulations (60,000 IU oral; injectable preparations)
Unscheduled: Low-dose oral forms (≤2000 IU daily formulations)

Routes

Oral, Intramuscular

Formulations

Tablets: 400 IU, 1000 IU, 2000 IU
Chewable tablets: 1000 IU, 2000 IU
Granules/Sachets: 60,000 IU
Soft gelatin capsules: 60,000 IU
Oral drops/solution: 400 IU/mL, 800 IU/mL (paediatric formulations)
Injection (IM): 300,000 IU/mL (1 mL ampoule), 600,000 IU/1.5 mL ampoule
Fixed-dose combinations: With calcium carbonate (various strengths — e.g., Calcium 500 mg + Vitamin D3 250 IU/500 IU)

Adult indications

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Vitamin D Deficiency (Nutritional or Malabsorption-related)

Serum 25(OH)D <20 ng/mL = Deficiency; 20–30 ng/mL = Insufficiency

Parameter	Recommendation
Starting dose (Loading)	60,000 IU orally once weekly for 6–8 weeks
Titration	Based on 25(OH)D levels after 8 weeks; continue weekly if still deficient
Usual maintenance dose	1,000–2,000 IU daily OR 60,000 IU once monthly
Maximum dose	60,000 IU weekly during loading; daily dose equivalent should not exceed 4,000 IU/day long-term without specialist supervision

Clinical Notes:

Recheck 25(OH)D level 6–8 weeks after completing loading dose
Target 25(OH)D level: 30–60 ng/mL
Maintenance regimen tailored to response; monthly dosing preferred for adherence

2. Osteomalacia (Adults) / Rickets (Children)

Parameter	Adults	Children (see Paediatric section)
Starting dose	60,000 IU orally once weekly for 8–12 weeks	Weight/age-based (see below)
Titration	Continue based on clinical and biochemical response	As per specialist
Usual maintenance dose	1,000–2,000 IU daily (with calcium supplementation)	400–1,000 IU daily
Maximum dose	60,000 IU weekly during treatment phase	Age-dependent

Clinical Notes:

Co-administer calcium (1,000–1,500 mg/day elemental calcium in divided doses)
Monitor serum calcium, phosphate, alkaline phosphatase
Radiological improvement expected in 2–4 weeks in rickets

3. Osteoporosis (Supportive Therapy)

Parameter	Recommendation
Starting dose	800–2,000 IU daily with calcium
Titration	Not applicable
Usual maintenance dose	800–2,000 IU daily
Maximum dose	4,000 IU daily without specialist supervision

Clinical Notes:

Always combine with adequate calcium intake (dietary or supplemental)
Part of comprehensive osteoporosis management (with bisphosphonates, etc.)
60,000 IU monthly acceptable alternative for poor adherence

4. Hypoparathyroidism (Adjunctive Therapy)

Parameter	Recommendation
Starting dose	1,000–2,000 IU daily
Titration	Increase based on serum calcium response; may require 2,000–4,000 IU/day
Usual maintenance dose	1,000–4,000 IU daily
Maximum dose	4,000 IU daily (higher doses under specialist supervision with active vitamin D analogues)

Clinical Notes:

Usually combined with calcium supplementation and/or calcitriol
Close monitoring of serum calcium essential
Active vitamin D (calcitriol) often preferred for calcium control

Secondary Indications — Adults Only (Off-label)

Indication	Dose	Duration	Notes
Chronic Kidney Disease (non-dialysis, stages G1–G3b with 25(OH)D <30 ng/mL) — OFF-LABEL	1,000–2,000 IU daily OR 60,000 IU monthly	Long-term with monitoring	Specialist (Nephrology) supervision. Based on KDIGO and Indian nephrology practice. Monitor PTH, calcium, phosphate.
Chronic Liver Disease with Vitamin D Insufficiency — OFF-LABEL	2,000 IU daily OR 60,000 IU monthly	Long-term	Hepatology specialist. Impaired 25-hydroxylation may limit response. Monitor 25(OH)D and calcium. Based on Indian hepatology protocols.
Autoimmune Conditions (adjunctive — e.g., multiple sclerosis, rheumatoid arthritis) — OFF-LABEL	1,000–2,000 IU daily	Long-term	Specialist only. Evidence variable. Ensure sufficiency without toxicity. Based on emerging RCT data.

Paediatric indications

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

1. Prophylaxis of Vitamin D Deficiency (Exclusively Breastfed Infants)

Age Group	Dose	Frequency	Duration
Birth to 12 months	400 IU	Once daily	Until weaning to vitamin D-fortified diet
1–18 years (if at risk)	400–1,000 IU	Once daily	Ongoing if dietary intake inadequate

Dosing Structure:

Parameter	Recommendation
Starting dose	400 IU daily from birth
Titration	Not applicable for prophylaxis
Usual maintenance dose	400 IU daily
Maximum dose	1,000 IU daily for prophylaxis

2. Nutritional Rickets / Vitamin D Deficiency (Treatment)

Age-based Dosing:

Age Group	Loading Dose	Duration	Maintenance Dose
Neonates (<1 month)	1,000–2,000 IU daily	6–8 weeks	400 IU daily
Infants (1–12 months)	2,000 IU daily OR 60,000 IU weekly for 6 weeks	6–8 weeks	400–1,000 IU daily
Children (1–12 years)	60,000 IU weekly	6–8 weeks	400–1,000 IU daily
Adolescents (>12 years)	60,000 IU weekly	6–8 weeks	1,000–2,000 IU daily

Dosing Structure (Children 1–12 years):

Parameter	Recommendation
Starting dose	60,000 IU orally once weekly
Titration	Continue weekly if 25(OH)D remains <30 ng/mL after 6 weeks
Usual maintenance dose	400–1,000 IU daily
Maximum dose	60,000 IU weekly during loading; avoid exceeding 2,000 IU daily equivalent for maintenance

Alternative Loading Regimen:

3,000–6,000 IU daily for 12 weeks (age-adjusted)

IM Injection (Specialist Only):

Reserved for severe malabsorption, poor oral adherence, or severe symptomatic rickets
300,000 IU IM single dose — repeat after 3 months if needed
Close calcium monitoring essential post-injection

Secondary Indications — Paediatric (Off-label)

Indication	Age	Dose	Duration	Notes
Chronic Kidney Disease (Stages 2–3)— OFF-LABEL	>1 year	1,000–2,000 IU daily (adjusted to 25(OH)D level)	Long-term	Paediatric nephrology only. Monitor calcium, phosphate, PTH. Based on KDIGO paediatric recommendations adapted for Indian practice.
Chronic Liver Disease — OFF-LABEL	>1 year	2,000–4,000 IU daily or equivalent	Long-term	Paediatric gastroenterology/hepatology only. May require active vitamin D analogues. Limited efficacy due to impaired hepatic hydroxylation.
Malabsorption Syndromes (Coeliac, IBD) — OFF-LABEL	>1 year	Higher doses (2,000–4,000 IU daily) based on 25(OH)D levels	Long-term	Specialist only. May require parenteral supplementation.

Age Restrictions:

Oral low-dose vitamin D (400 IU daily) is safe from birth
High-dose therapy (≥60,000 IU single dose) generally avoided in infants <12 months except under specialist supervision
IM injections: Not recommended below 1 year except in exceptional circumstances

Safety Monitoring in Children:

Serum calcium: 3–4 weeks after starting high-dose therapy
25(OH)D level: 6–8 weeks after loading course
Monitor for symptoms of hypercalcaemia (vomiting, constipation, irritability, lethargy)
Growth monitoring with long-term supplementation

Renal Adjustments

CKD Stage	eGFR (mL/min/1.73m²)	Recommendation
G1–G2	>60	No dose adjustment. Standard dosing for deficiency.
G3a–G3b	30–59	No dose adjustment. Monitor 25(OH)D, calcium, phosphate, PTH every 3–6 months.
G4	15–29	Use with caution. Specialist supervision. Monitor closely. Consider calcitriol/alfacalcidol if PTH elevated.
G5 / Dialysis	<15	Specialist only. Cholecalciferol may be used to correct 25(OH)D deficiency, but active vitamin D analogues (calcitriol, alfacalcidol) usually required for calcium-PTH management.

CKD Stage	eGFR (mL/min/1.73m²)	Recommendation
G1–G2	>60	No dose adjustment. Standard dosing for deficiency.
G3a–G3b	30–59	No dose adjustment. Monitor 25(OH)D, calcium, phosphate, PTH every 3–6 months.
G4	15–29	Use with caution. Specialist supervision. Monitor closely. Consider calcitriol/alfacalcidol if PTH elevated.
G5 / Dialysis	<15	Specialist only. Cholecalciferol may be used to correct 25(OH)D deficiency, but active vitamin D analogues (calcitriol, alfacalcidol) usually required for calcium-PTH management.

Note: In advanced CKD, renal 1α-hydroxylase activity is reduced, limiting conversion of 25(OH)D to active 1,25(OH)₂D. Active vitamin D analogues are often needed.

Hepatic adjustment

Contraindications

Hypercalcaemia (serum calcium >10.5 mg/dL or ionised calcium elevated)
Hypervitaminosis D (25(OH)D >100 ng/mL with symptoms)
Known hypersensitivity to cholecalciferol or any formulation component (e.g., peanut oil in some preparations)
Severe hyperphosphataemia (without specialist management)
Metastatic calcification

Cautions

Granulomatous diseases (sarcoidosis, tuberculosis, histoplasmosis) — extra-renal 1α-hydroxylase activity may cause hypercalcaemia
Nephrolithiasis history — particularly calcium-containing stones
Concurrent use of high-dose calcium supplements
Concurrent thiazide diuretic use — increased hypercalcaemia risk
Fat malabsorption syndromes — may require higher doses or parenteral route
Advanced CKD (G4–G5) — reduced conversion to active form
Concurrent use of medications affecting vitamin D metabolism (anticonvulsants, rifampicin)
Elderly with reduced renal reserve
Infants and children — accurate dosing essential to avoid toxicity

Pregnancy

Parameter	Information
Overall safety	Safe at recommended doses; deficiency is common in pregnancy in India
Recommended intake	400–2,000 IU daily; up to 4,000 IU/day considered safe
High-dose regimens	60,000 IU weekly may be used for deficiency correction under supervision
Risk assessment	No evidence of teratogenicity at therapeutic doses; hypervitaminosis D may cause fetal hypercalcaemia
Preferred alternatives	Cholecalciferol is preferred over ergocalciferol
When to use	Routine supplementation recommended for all pregnant women in India (as per MoHFW guidelines)
Monitoring	Serum calcium if on high-dose therapy; standard antenatal care otherwise

Lactation

Parameter	Information
Compatibility	Compatible with breastfeeding
Recommended dose	Maintenance doses (1,000–2,000 IU daily) are safe
Milk levels	Low at routine doses; increases with maternal supplementation but remains within safe limits
High-dose therapy	Single doses of 60,000 IU monthly are acceptable; avoid repeated megadoses (e.g., >300,000 IU)
Preferred alternatives	None required; cholecalciferol is the preferred form
Infant monitoring	Routine; observe for signs of hypercalcaemia if mother on very high doses (irritability, poor feeding, constipation)

Note: Maternal high-dose supplementation (e.g., 4,000–6,400 IU/day) can increase breast milk vitamin D content sufficiently to meet infant requirements — an alternative strategy to direct infant supplementation (research-based, not yet standard practice in India).

Elderly

Parameter	Recommendation
Starting dose	800–1,000 IU daily for maintenance; 60,000 IU weekly for deficiency
Titration	Based on 25(OH)D response
Usual maintenance dose	800–2,000 IU daily
Special considerations	Higher prevalence of deficiency; reduced skin synthesis and dietary intake
Benefits	Adequate vitamin D associated with reduced fall risk and improved muscle function
Risks	Hypercalcaemia (especially with concurrent thiazide use); reduced renal reserve may impair calcium handling
Monitoring	25(OH)D and serum calcium every 6–12 months; renal function baseline and periodically

Major drug interactions

Drug/Class	Interaction	Mechanism	Management
Thiazide diuretics	Increased risk of hypercalcaemia	Thiazides reduce renal calcium excretion	Monitor serum calcium, especially in elderly. Use lower vitamin D doses if needed.
Digitalis glycosides(digoxin)	Hypercalcaemia potentiates digitalis toxicity (arrhythmias)	Calcium enhances digitalis cardiac effects	Avoid hypercalcaemia; monitor calcium and for signs of digitalis toxicity
Phenytoin, Phenobarbital, Carbamazepine	Reduced vitamin D efficacy	Hepatic enzyme induction accelerates vitamin D metabolism	Higher vitamin D doses may be required (2,000–4,000 IU/day). Monitor 25(OH)D levels.
Rifampicin	Reduced vitamin D efficacy	CYP450 induction	Higher doses may be needed during TB treatment. Monitor 25(OH)D.

Moderate drug interactions

Drug/Class	Interaction	Management
Glucocorticoids(prednisolone, dexamethasone)	May reduce intestinal calcium absorption and impair vitamin D action	Higher vitamin D doses (1,000–2,000 IU/day) recommended during chronic steroid therapy
Cholestyramine, Colestipol	Reduced vitamin D absorption	Administer vitamin D ≥2 hours before or 4–6 hours after bile acid sequestrants
Orlistat	Reduced fat-soluble vitamin absorption	Take vitamin D at bedtime (separate from orlistat); consider higher doses
Aluminium-containing antacids	May reduce vitamin D absorption	Separate administration; avoid prolonged concurrent use
High-dose calcium supplements	Combined hypercalcaemia risk	Monitor serum calcium periodically; limit total elemental calcium to ≤1,500 mg/day from all sources
Calcitriol/Alfacalcidol	Additive hypercalcaemia risk	Use combination under specialist supervision with close calcium monitoring

Common Adverse effects

At standard doses (≤2,000 IU/day):

Generally well tolerated
Rare: mild GI upset

At high doses (≥60,000 IU/week, especially prolonged):

Nausea
Constipation
Abdominal discomfort
Headache
Metallic taste
Fatigue

Serious Adverse effects

Effect	Notes
Hypercalcaemia	Most important toxicity. Symptoms: polyuria, polydipsia, anorexia, nausea, vomiting, constipation, weakness, confusion, cardiac arrhythmias. Discontinue vitamin D and calcium immediately. Rehydrate. Seek specialist input.
Hypercalciuria	Precedes hypercalcaemia; monitor urinary calcium if prolonged high-dose therapy
Nephrocalcinosis / Nephrolithiasis	With chronic excessive dosing. May lead to CKD.
Acute Kidney Injury	Secondary to severe hypercalcaemia and nephrocalcinosis
Metastatic calcification	Rare; soft tissue calcium deposits with prolonged toxicity
Seizures (infants)	Due to severe hypercalcaemia from dosing errors. Emergency management required.

Monitoring requirements

Timing	Parameters
Baseline	Serum 25(OH)D (if available); serum calcium and phosphate; renal function (creatinine, eGFR); consider PTH in suspected metabolic bone disease
After loading dose (6–8 weeks)	Serum 25(OH)D to assess response; serum calcium if high-dose therapy used
High-dose therapy	Serum calcium every 4–6 weeks during loading phase
Long-term maintenance	25(OH)D every 6–12 months to ensure adequacy; serum calcium annually or if symptoms suggest hypercalcaemia
Special populations (CKD, granulomatous disease)	Calcium, phosphate, PTH every 3 months; more frequent initially
Paediatric high-dose therapy	Serum calcium 3–4 weeks after initiation

Target Levels:

25(OH)D: 30–60 ng/mL (75–150 nmol/L)
Avoid sustained levels >100 ng/mL (toxicity risk)

Brands in India

Single Ingredient:

D-Rise (USV)
Uprise-D3 (Alkem)
Tayo 60K (Eris)
Arachitol (Abbott) — also available as injection
Calcirol (Cadila)
D3 Must (Mankind)
Depura (Sanofi)
Calcitas D3 (Intas)

Paediatric Formulations (Drops/Syrup):

D-Drops (various)
Zydrop D3 (Zydus)
Uprise D3 drops

Injectable:

Arachitol 300,000 IU/mL, 600,000 IU/1.5 mL (Abbott)

Fixed-Dose Combinations (with Calcium):

Shelcal 500/HD (Torrent)
Calcimax (Meyer)
CCM (Abbott)
Gemcal (Ipca)
Macalvit (Macleods)
Calvit D3 (Alkem)

Price range (INR)

Formulation	Price Range
Sachet 60,000 IU	₹20–50 per sachet
Capsule 60,000 IU	₹18–45 per capsule
Tablet 1,000 IU	₹2–6 per tablet
Oral drops 400 IU/mL (15 mL)	₹80–150 per bottle
Injection 300,000 IU (1 mL)	₹80–160 per ampoule
Injection 600,000 IU (1.5 mL)	₹120–200 per ampoule
Calcium + D3 FDC tablets	₹3–10 per tablet

Note: Cholecalciferol is included in NLEM 2022 (oral formulations). Available in government supply and Jan Aushadhi outlets at lower cost.

Clinical pearls

Standard Indian regimen: 60,000 IU weekly × 6–8 weeks followed by monthly maintenance is effective, safe, and improves adherence compared to daily low-dose regimens.
Always co-prescribe calcium: During repletion of severe deficiency/rickets/osteomalacia, ensure adequate calcium intake (dietary or supplemental, 1,000–1,500 mg/day elemental calcium) to prevent "hungry bone" syndrome.
Daily dose equivalent ceiling: Long-term intake should not exceed 4,000 IU/day equivalent without specialist supervision and monitoring — higher doses increase hypercalcaemia risk.
IM injection caveats: Reserve for genuine malabsorption or documented non-adherence. Single large doses may cause transient hypercalcaemia — monitor calcium 2–4 weeks post-injection.
CKD considerations: Cholecalciferol corrects 25(OH)D deficiency but does not address secondary hyperparathyroidism in advanced CKD — calcitriol or alfacalcidol often needed additionally.
Drug-induced deficiency: Patients on anticonvulsants (phenytoin, carbamazepine) or rifampicin require higher vitamin D doses prophylactically — accelerated hepatic metabolism.

Version

RxIndia v1.0 — 05 Jan 2025

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Clinical Responsibility

This platform is designed strictly for healthcare professionals. Data provided is synthesized from authoritative pharmacological sources and clinical registries. Do not use for consumer medical decisions. Always verify critical dosing and contraindications with official institutional protocols and peer-reviewed journals.

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